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Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?

This study has been completed.
Sponsor:
Collaborator:
National Cattlemen's Beef Association
Information provided by:
USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT00700804
First received: June 18, 2008
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

The primary objective is to determine whether meat interacts positively with calcium to improve calcium retention. The secondary objective is to determine whether any interaction between dietary protein and calcium affects biomarkers of bone metabolism.


Condition Intervention
Dietary Proteins
Behavioral: High Protein Diet
Behavioral: Low Protein Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?

Resource links provided by NLM:


Further study details as provided by USDA Grand Forks Human Nutrition Research Center:

Primary Outcome Measures:
  • Calcium Absorption [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
    Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time


Secondary Outcome Measures:
  • Serum Insulin-like Growth Factor 1 (IGF-1) [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: June 2003
Study Completion Date: January 2005
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Calcium Diet Behavioral: High Protein Diet
High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm
Experimental: Low Calcium Diet Behavioral: Low Protein Diet
High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm

Detailed Description:

This study tests the effects of dietary protein and calcium on calcium retention and indices of bone metabolism. It is a controlled feeding trial with a randomized crossover design (2x2 Factorial), studying 34 healthy post-menopausal women. The women are blocked on Body Mass Index (weight in kilograms divided by height in meters squared)and randomly assigned to a high calcium (HC,1500 milligrams per day) or low calcium (LC, 600 milligrams per day) group, and consume both low protein (LP,10% protein) and high protein (HP, 20% protein) diets for 7 weeks each. There is a 3-week "washout" between dietary periods, during which the subjects consume self-selected diets. After 3 week equilibration to each diet, the 2-day rotating menu is extrinsically labeled with a Calcium-47 radiotracer and retention is monitored for 28 days by whole body scintillation counting. In addition to Calcium retention, other endpoints include urinary indices of acid excretion and urine serum indices of bone resorption.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • at least 3 years since last menses
  • bone mineral density equal to or greater than 2.5 standard deviations from average bone mineral density for young adults,
  • body mass index equal to or less than 35 kilograms/meter squared

Exclusion Criteria:

  • taking prescription medication other than hormone replacement therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700804

Locations
United States, North Dakota
United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, United States, 58202
Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center
National Cattlemen's Beef Association
Investigators
Principal Investigator: Janet R Hunt, PhD USDA Grand Forks Human Nutrition Research Center
  More Information

No publications provided

Responsible Party: Janet R Hunt, PhD, Research Nutritionist, United States Department of Agriculture (USDA) Grand Forks Human Nutriton Research Center
ClinicalTrials.gov Identifier: NCT00700804     History of Changes
Other Study ID Numbers: GFHNRC064, IRB-200307-010
Study First Received: June 18, 2008
Results First Received: December 30, 2008
Last Updated: May 31, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by USDA Grand Forks Human Nutrition Research Center:
Calcium retention
dietary protein
dietary calcium

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014